Kornimate/medical-research-clean huggingface dataset:
promoting optimal treatment choices in neonates with suspected early-onset sepsis

Conditions: Early-onset Sepsis

Summary: in this study, three neonatal evidence-based antibiotic stewardship strategies will be implemented in dutch hospitals. these include the early-onset sepsis (eos) calculator, procalcitonin (pct)-guided therapy, and iv-to-oral switch therapy. these strategies have been proven to be effective and safe and are already applied in several dutch hospitals. however, this is not the case for all hospitals, leading to significant variations in clinical practice. to facilitate the translation of evidence into practice, active implementation will take place. the primary research design is a prospective implementation study, using a multicenter, non-randomized pre-post design. the aim is to assess the impact of implementing a bundle of antibiotic stewardship interventions (including the eos calculator, pct-guided therapy and iv-to-oral switch therapy) in dutch hospitals, using a multicomponent implementation strategy, on both clinical and implementation outcomes, with a particular focus on evaluating the employed implementation strategies. a combination of qualitative and quantitative research methods will be used to assess outcomes. quantitative clinical data from neonates in the pre- and post-implementation periods will be retrospectively collected by the business intelligence units of participating hospitals and pseudonymized before being provided to the central research team. qualitative data will be gathered through focus groups, interviews, and surveys.


Eligibility criteria:
inclusion criteria: * neonates born at 34 weeks of gestation or later * 0-3 days old exclusion criteria: * stillborn neonates

Keywords: early-onset sepsis neonatal sepsis early-onset sepsis calculator pct-guided therapy iv-to-oral switch therapy implementation
postprandial lipid tracer and exercise in spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this study investigates the effect of upper extremity exercise on postprandial lipemia (ppl) in persons with spinal cord injury (sci). participants are measured at rest and fed a standardized meal following seated rest (con) or arm cycling exercise (ace). the meal is infused with "stable isotope lipid tracers" that allow for determination of the end fates of the fat in the meal.

spinal cord injury (sci) results in dysregulation of fat metabolism that increases the risk of morbidity and mortality from cardioendocrine disease. excessive accumulation of visceral fat after sci is a serious risk component for cardioendocrine disease and results in part from pronounced hypertriglyceridemia following ingestion of fat-containing meals (i.e., exaggerated postprandial lipemia; ppl). although exaggerated ppl is well documented in persons with sci, its etiology is unknown. specifically, it remains to be determined to what extent exaggerated ppl in those with sci results from impairments in the use of exogenous (dietary) and/or endogenous (stored) fats. additionally, it is not known if exercise improves postprandial fat use in a manner that alleviates the exaggerated ppl in this population and reduces the risk of cardioendocrine disease. the objective of the this study is to examine the mechanisms of exaggerated ppl in those with sci and the effects of an acute pre-meal exercise bout by employing novel stable isotope tracer techniques. in persons without sci, it is well established that pre-meal exercise lowers ppl in part by improving the use of exogenous and endogenous fats. while muscle atrophy and blunted sublesional sympathetic activity following sci may hinder fat use, preliminary data indicate that fat use is increased during recovery from exercise in the postabsorptive (fasted) state in this population. thus, the investigators hypothesize that decreased use of exogenous and endogenous fats contributes to exaggerated ppl in sci, and that pre-meal exercise will reduce ppl due to increased use of both fat sources.

Eligibility criteria:
inclusion criteria: * males aged 18-60 years. * for the spinal cord injury subgroups, the participant's injury will be: * neurologically stable, * american spinal injury association (asia) impairment scale a-c, * and will have occurred \> 1 year from the testing date. exclusion criteria: * existing diagnosis of cardiovascular disease or diabetes. * contraindication to exercise (acsm guideline, 10th edition). * lower extremity fracture or dislocation within 6 months of participation. * history of head injury or seizures. * inability to consent. * restrictions in upper extremity range of motion that would prevent an individual from achieving an unhindered arm cycling motion or moving throughout a range needed to perform resistance maneuvers. * a pressure ulcer at ischial/gluteus, trochanteric, sacral, or heel sites within the last 3 months. * imprisonment in state or federal jail or prison.

Keywords: lipemia feeding paraplegia tetraplegia physical activity macronutrient metabolism
sternal fixation with stern fix after medial sternotomy

Conditions: Sternotomy

Summary: the goal of this single arm observational registry is to evaluate the safety and performance of the stern fix device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use. the main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the stern fix system. participants will have their sternotomy closed with the stern fix device at the end of their cardiothoracic surgery and will be followed up as per standard of care. at discharge and at the 1 month fu visit the sternal stability will be assessed using the sternal instability scale (sis).


Eligibility criteria:
inclusion criteria: * older than 18 years old patient * patient undergoing surgery requiring medial sternotomy * patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry exclusion criteria: * patients that are still growing. * patients with sternal anomalies preventing the use of the stern fix sternal stabilization system, such as bone tumors located in the implant region. * patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage. * patients with suspected or known allergies or intolerances to the implant material. * patients with severe osteoporosis or other degenerative bone diseases. * any patient unwilling to, or incapable of, following postoperative care instructions. * patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant. * pregnant patients or planning to become pregnant during the 2 months following surgery. * patients with life expectancy lower than 2 months. * patients who are or have been participating in an interventionist trial during the last 4 weeks intraoperative exclusion criteria * latent or active infection, or inflammation in the operating area. * signs of infection on the surgical site. * parasternal sternotomy. * when the stern fix sternal stabilization system cannot ensure sufficient fixation. * when a stern fix sternal stabilization system device cannot be placed properly in any intercostal space.

Keywords: rigid fixation sternal closure stern fix
the effects of a home exercise video programme for patients with copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: patients with copd, suffer symptoms of breathlessness and leg weakness. exercise programmes in the form of pulmonary rehabilitation (pr) have been shown to improve both of these symptoms significantly. pr involves patients attending a hospital or community centre. for some patients, leaving the house is an ordeal. this study investigated the effectiveness of an exercise video programme delivered in the patients home.

pulmonary rehabilitation (pr) has been shown to deliver cost-effective improvements in dyspnoea, exercise tolerance and health-related quality of life (hrqol) in people with chronic obstructive pulmonary disease (copd). pr programmes in the united kingdom (uk) are typically delivered on an outpatient basis, either at a hospital or suitable site in the community. it is not always possible however, for patients to access outpatient programmes due to lack of local availability or adequate transport from isolated locations. severe breathlessness may reduce activity levels to such a degree that for many leaving the house is an ordeal. a british lung foundation (blf) survey reported that less than 2% of uk copd patients had access to a rehabilitation exercise programme, despite national institute for health and clinical excellence (nice) and british thoracic society (bts) recommendations that pr be made available to all patients who are functionally limited by dyspnoea. meeting the demand for pr remains a challenge. access to the benefits of pr may be broadened if effective exercise could be administered at home. current evidence suggests that home-based rehabilitation interventions result in smaller benefits as judged by exercise tolerance and quality of life when compared to supervised programmes. the impact of home based rehabilitation may be limited by multiple factors including, lack of health care professional supervision and lack of support from fellow copd sufferers. this lack of support may lead to poor adherence to prescribed exercise intensity and frequency in home programmes. one-to-one supervision on an individual basis is unlikely to be feasible or cost-effective, however, use of a home exercise video could enhance adherence to prescribed exercise programmes. video media can be an effective means of delivering exercise instruction. no published research to date has investigated the effectiveness of a home exercise video for patients with copd. we hypothesised that an exercise programme based on video instruction at home, could improve walking ability, breathlessness and quality of life.

Eligibility criteria:
inclusion criteria: * moderate/severe copd * access to a video or dvd player exclusion criteria: * comorbid condition that precludes safe exercise * previous attendance at a pulmonary rehabilitation programme

Keywords: copd exercise home
study of coronary artery computed tomography to diagnose emergency chest pain

Conditions: Chest Pain; Angina Pectoris; Myocardial Infarction

Summary: the purpose of this study is to determine whether coronary artery computed tomography scanning is a more rapid, less expensive and safe alternative to standard diagnostic evaluation of patients with acute chest pain in the emergency room.

over 6 million patients per year visit hospital emergency departments for evaluation of chest pain, with diagnostic costs estimated to be in excess of $10 billion. standard diagnostic evaluation often includes 8-12 hours of serial laboratory tests followed by stress imaging studies requiring an additional 4-8 hours. multi-slice coronary artery computed tomography scanning (msct) has been shown to be a highly accurate diagnostic method in comparison to invasive angiography. because of its speed and high negative predictive value, msct could rapidly screen patients for the presence of coronary disease, which may expedite their care. this study compares the length of stay and cost of care in emergency chest pain patients randomly assigned to initial evaluation by msct compared to patients randomly assigned to a standard diagnostic evaluation including single photon emission computed tomography scanning. the study follows these patients to detect major adverse cardiac events including unstable angina, acute myocardial infarction or death over a 90-day period.

Eligibility criteria:
inclusion criteria: * chest pain or angina equivalent symptoms. * age ≥ 25 years. * low risk of infarction and/or complications by goldman/reilly criteria. exclusion criteria: * known coronary artery disease. * electrocardiogram diagnostic of acute cardiac ischemia and/or infarction. * elevated serum biomarkers including creatine kinase (ck) mb, myoglobin, and/or cardiac troponin i on initial testing. * contraindication to iodinated contrast and/or beta blocking drugs. * atrial fibrillation or markedly irregular rhythm. * pregnancy. * renal insufficiency, creatinine \> 1.5 mg/dl. * iodinated contrast within prior 48 hours.

Keywords: chest pain angina pectoris emergency medicine spiral computed tomography length of stay cost analysis
adaptive intervention to facilitate prep uptake/adherence among transgender women

Conditions: Prevention

Summary: "prep n' shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of pre-exposure prophylaxis (prep) in transgender women (tgw).

the "prep n' shine" package includes two behavioral intervention components: 1. peer-led, strengths-based case management (sbcm) for prep linkage and uptake, and 2. a resource-efficient, adaptive "stepped-care" technology and counseling intervention that addresses individualized barriers to optimal use. stage 1: tgw will be equally randomized to receive either the strengths-based case management or standard of care referral to prep clinic. stage 2: those from stage 1 who initiate prep , regardless of stage 1 randomization condition, will then be equally randomized to either the "prep n' shine" adherence intervention or standard of care comparison condition.

Eligibility criteria:
inclusion criteria: * age: 18 years or older * male sex at birth * self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum * prep naïve * prep indicated per cdc guidelines (incl. hiv negative) * owns a cell phone or willing to use one in the study * able to understand and speak english or spanish exclusion criteria: * unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit * has lived in ri for less than three months (as a means to enhance participant retention) * discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved) * laboratory or clinical findings that would preclude prep initiation (e.g. hepatitis b infection, decreased creatinine clearance)

Keywords: transgender women (tgw) hiv prevention prep
exploring the role of adipocyte fatty acid binding protein in the association of obstructive sleep apnea and metabolic dysfunction

Conditions: Obstructive Sleep Apnea; Insulin Resistance; Metabolic Syndrome; Inflammation

Summary: adipocyte fatty acid binding protein (a-fabp) is a member of the fabp super family, is abundant in adipocytes and macrophages. regulatory functions of a-fabp in lipid and glucose metabolism have been described, and it is suggested to play an important role in the pathogenesis of metabolic syndrome.we hypothesize that obstructive sleep apnea (osa) may upregulate a-fabp production and thus causally contribute to metabolic dysfunction. our group has recently demonstrated that a-fabp, expressed and secreted from adipocytes, is present in the blood stream .the levels of a-fabp correlated with various metabolic variates in the metabolic syndrome. furthermore, we have obtained novel data in men with a range of sleep disordered breathing showed that the duration of oxygen desaturation correlated with circulating levels of a-fabp, independent of age and waist/body mass index. the current proposal aims to pursue this finding and further explore the role of a-fabp in the association of osa and metabolic dysfunction.

we hypothesize that there are changes in circulating a-fabp level which can be mitigated by effective treatment of osa. the aim is to investigate the effect of cpap treatment of osa on circulating a-fabp, and other metabolic biomarkers and cardiovascular parameters

Eligibility criteria:
inclusion criteria: * subjects between 18 - 65 years old * able to understand and give informed written consent exclusion criteria: * bmi \> 35 kg/m2, and features of obesity hypoventilation syndrome * known diabetes mellitus or hyperlipidemia on treatment * known cardiovascular disease except hypertension stable on treatment * unstable medical illness * need for starting treatment for osa or other medical conditions immediately

Keywords: obstructive sleep apnea metabolic dysfunction metabolic syndrome adipocyte fatty acid binding protein
economic analysis of blood product transfusions according to the treatment of acute myeloid leukaemia in the elderly

Conditions: Acute Myeloid Leukemia

Summary: blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (aml). in addition to an increase prevalence of co morbidities in older patients, aml in older patients is more often associated with adverse features than in younger adults. physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. an alternative treatment could be low-intensity therapy, such as ld-arac or hypomethylating agents, which demonstrated better results than only best supportive care (bsc). blood transfusion requirement represents one of the most significant cost driver associated with aml. the present study assesses the cost-effectiveness of intensive chemotherapy versus best supportive care (bsc) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (ld-arac), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a french payer perspective. intensive chemotherapy and bsc were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly aml according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 70 years old * aml according to the world health organization (who) criteria (% of blasts ≥ 20% in bone marrow aspiration). * all fab subtypes. * any type of aml (de novo or secondary) * all participants to clinical trials gave their written informed consent exclusion criteria: * have an eastern cooperative oncology group (ecog) score ≥2 * active uncontrolled infection

Keywords: acute myeloid leukemia therapy blood transfusion cost-effectiveness prognosis
effects of wbv associated with imt on functionality

Conditions: Frail Elderly Syndrome

Summary: the pre-frail elderly are a population more vulnerable to diminished functionality and future disabilities. thus, interventions focused on the prevention of sarcopenia are indicated to prevent dysfunction in this population. this study aims to evaluate the effects of whole body vibration training associated with inspiratory muscle training on functional outcomes, balance and muscle metabolism in pre-frail elderly women.


Eligibility criteria:
inclusion criteria: * to able to walk without assistance * good understanding to carry out the proposed tests, evaluated through the mini mental state examination (mmse). exclusion criteria: * contraindication or difficulty to perform evaluation procedures * users of medications that interfere with the cardiovascular and / or muscular system * smokers * neuromuscular or degenerative diseases * pulmonary comorbidities * heart diseases and labyrinthitis

Keywords: aging functional capacity muscle metabolism
incomplete total body protein recovery in adolescent patients with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the study aimed to assess protein accretion during weight gain in adolescent patients with anorexia nervosa

background: bone health and growth during adolescence require adequate total body protein (tbpr). re-nutrition for patients with anorexia nervosa (an) should aim to normalize body composition, i.e. recovery of fat mass and tbpr. objective: the study intended to analyze predictors of protein status, including exercise status, in adolescents with an, and to investigate whether weight gain would replete body protein deficits. methods: the investigators assessed tbpr in a longitudinal, observational study as height-adjusted nitrogen index (ni) using in-vivo neutron activation analysis in adolescents with an at the commencement of refeeding (t0), as well as seven months thereafter (t1), and in age-matched normal weight controls. lean tissue and fat mass were assessed with dual-energy x-ray absorptiometry (dxa). bmi, bmi-sds and lean tissue mass were tested as predictors of protein status using receiver operating characteristic (roc) analysis.

Eligibility criteria:
patient inclusion criteria: * diagnosis of anorexia nervosa (dsm-iv) * aged 12 - 19 years * female gender patient exclusion criteria: - existence of a further disease with effect on body composition controls: * no known disease * normal weight

Keywords: body composition total body protein nutritional recovery exercise status in-vivo neutron activation analysis protein depletion
assessments of thrombus formation in tavi

Conditions: Aortic Valve Stenosis; Heart Valve Diseases

Summary: transcatheter aortic valve implantation (tavi) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (as) who are inoperable or have high surgical risk. although the rates of periprocedural bleeding events are lower in tavi compared to those in surgical aortic valve replacement, those in tavi still remains high. in addition, current guideline recommended the dual antiplatelet (dapt), clopidogrel plus aspirin, for a 3- to 6-month period after tavi, however no evidences supports this approach. the antithrombotic regimen in patients undergoing tavi is needed to be established. to establish the antithrombotic regimen in patients undergoing tavi, 1. the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing tavi measured by total thrombus formation analysis system (t-tas). 2. the investigators analyze plasma micrornas, and shear stress by using computational fluid dynamics (cfd) to clarify the mechanistic factors regarding those changes.


Eligibility criteria:
inclusion criteria: * twenty years and older * with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated) exclusion criteria: * withdrawn the informed consent * patients with trans-apical approach * critical illness condition (severe infectious disease, cancer, severe bleeding disorder) * transition to the surgical avr

Keywords: transcatheter aortic valve implantation